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Stem cell therapy for ALS.

Clinics inject cells into the spinal fluid to slow ALS. The only cell therapy taken through a full placebo-controlled trial missed its goal, and more people died in the treated group.[1]

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Written by Eli McGarvie.

Clinics that treat ALS.

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All 3 clinics
ClinicConditionsTreatmentsPrice from
Celltex MéxicoCancún, Mexico ALSMSDiabetesArthritis MesenchymalIV Not disclosed Panama Cell TherapiesPanama City, Panama ALSAutismMSParkinson's MesenchymalInjections Not disclosed Vega Stem CellBangkok, Thailand ALSKneeArthritisAutism Umbilical cordMesenchymalIVInjections Not disclosed

What to expect

The procedure

Cells are injected into the spinal fluid by lumbar puncture, usually alongside a drip. Clinics say the effect wears off and sell repeat doses.[2]

How many sessions

Clinics sell a course of repeated spinal injections, with the number set by how many cells one harvest produces.[2] Families describe stopping part-way because the disease moved faster than the schedule, or because the travel and spinal taps were making things worse.[2]

Risks

Headache and back pain after the lumbar punctures affect a quarter to a third of people, mostly short-lived.[3][4] In the phase 3 trial, deaths and life-threatening events were more common in the treated group than on placebo.[1]

The only phase 3 trial failed, and more treated patients died

Does it work? No. Both properly blinded placebo-controlled trials were negative.[1][5] Small, temporary slowing seen in open studies did not survive blinding, and no trial has shown longer survival or better breathing.[6][7]

32.6% vs 27.7%responders with NurOwn against placebo, a difference that missed the trial's main goalPhase 3 trial, 189 people[1]
10 vs 3deaths in the treated group against placebo during the trialPhase 3 trial[1]
17 to 1FDA advisory committee vote against the trial showing effectiveness. The company withdrew its application.FDA advisory committee, September 2023[8]
8 of 13relatives who described a paid clinic treatment online said it did nothingOur review of patient accounts on Reddit and forums[2]

Where it is allowed

United States. No cell therapy is approved for ALS.[9] The FDA has warned a company selling cord products marketed for ALS.[10]

South Korea. Lenzumestrocel has a conditional approval based on 72 people. Its confirming trial finished in November 2024 and has published no results.[11][12]

Malaysia. Every cell product tested in ALS, except same-day bone marrow cells, must be registered first. None is registered for ALS.[13]

Mexico. COFEPRIS has said stem cell treatments lack authorisation.[14]

Common questions

Will it help me breathe for longer, or live longer?

Neither has been shown. Pooled analyses found breathing kept declining after treatment, in one faster than before, and the phase 3 trial found survival worse with treatment.[7][15][1]

Should I join a trial or pay a clinic?

ALS patient organisations advise taking the question to your own neurologist and using the trial registries rather than clinics.[16][17]

Questions to ask a clinic

  1. What did your patients' ALS function scores do before and after? Can I see the data?
  2. How many spinal injections, how far apart, and what if I cannot travel for the later ones?
  3. Which cells, and can I see the certificate for my batch?
  4. What symptoms after an injection mean I need a doctor straight away?
  5. Will my neurologist be involved?
  6. Will this rule me out of a clinical trial?

Sources

17 references
  1. US Food and Drug Administration, Center for Biologics Evaluation and Research. FDA Briefing Document: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting, September 27, 2023. BLA 125782, debamestrocel (MSC-NTF) for the treatment of amyotrophic lateral sclerosis (ALS), BrainStorm Cell Therapeutics, Inc. 2023. Link
  2. StemFinder review of first-hand patient accounts on Reddit and patient forums, 2026. Method
  3. Syková E, et al. Transplantation of Mesenchymal Stromal Cells in Patients With Amyotrophic Lateral Sclerosis: Results of Phase I/IIa Clinical Trial. Cell Transplantation, 2017. Link
  4. Nam JY, et al. Long-term survival benefits of intrathecal autologous bone marrow-derived mesenchymal stem cells (Neuronata-R®: lenzumestrocel) treatment in ALS: Propensity-score-matched control, surveillance study. Frontiers in Aging Neuroscience, 2023. Link
  5. Agüera-Morales E, et al. Adipose-derived mesenchymal stem cells for the treatment of Amyotrophic Lateral Sclerosis. A phase I/II safety and efficacy clinical trial. Frontiers in Neurology, 2025. Link
  6. Abdul Wahid SF, et al. Cell-based therapies for amyotrophic lateral sclerosis/motor neuron disease. The Cochrane Database of Systematic Reviews, 2019. Link
  7. Morata-Tarifa C, et al. Looking backward to move forward: a meta-analysis of stem cell therapy in amyotrophic lateral sclerosis. NPJ Regenerative medicine, 2021. Link
  8. US Food and Drug Administration, Center for Biologics Evaluation and Research. Summary Minutes, 75th Cellular, Tissue, and Gene Therapies Advisory Committee Meeting, September 27, 2023. 2023. Link
  9. U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, 2026. Link
  10. US Food and Drug Administration, Center for Biologics Evaluation and Research. Warning Letter: R3 Medical Companies (Bello Bio, LLC and Regen Suppliers, LLC), 726330, 08/14/2026. 2026. Link
  11. Nam JY, et al. Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial. Trials, 2022. Link
  12. Corestemchemon, Inc. Evaluation the Efficacy and Safety of Multiple Lenzumestrocel (Neuronata-R Inj.) Treatment in Patients With ALS. ClinicalTrials.gov, US National Library of Medicine, 2021. Link
  13. National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia, Second Edition (September 2025). 2025. Link
  14. Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). La COFEPRIS suspendió clínica del D.F. que ofrecía tratamientos con Células Madre sin aval científico. Gobierno de México, COFEPRIS (press release), 2015. Link
  15. Pourasghari M, et al. The Effectiveness Based on Optimal Dose and Administration Route, and Safety Profiles of Stem Cells and Derived Products in the Treatment of Patients With Amyotrophic Lateral Sclerosis: A Systematic Review and Meta-Analysis. Stem Cells International, 2026. Link
  16. International Alliance of ALS/MND Associations, Scientific Advisory Council. Unproven (Off-Label) Treatments. Alliance briefing note. International Alliance of ALS/MND Associations, 2023. Link
  17. MND Association. Stem cells and MND. Information Sheet F. Motor Neurone Disease Association (United Kingdom), 2022. Link

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